The following data is part of a premarket notification filed by Shenzhen Urion Technology Co., Ltd. with the FDA for Electronic Blood Pressure Monitor.
| Device ID | K141683 |
| 510k Number | K141683 |
| Device Name: | ELECTRONIC BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHENZHEN URION TECHNOLOGY CO., LTD. 4TH BUILDING, HI-TECH INDUSTRIAL ZONE, HEPING COMMUNITY, FUYONG STREET, BAOAN DISTRICT Shenzhen, CN 518103 |
| Contact | Autumn Liu |
| Correspondent | Autumn Liu SHENZHEN URION TECHNOLOGY CO., LTD. 4TH BUILDING, HI-TECH INDUSTRIAL ZONE, HEPING COMMUNITY, FUYONG STREET, BAOAN DISTRICT Shenzhen, CN 518103 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-23 |
| Decision Date | 2015-04-03 |
| Summary: | summary |